Diabetes care kit that is preconfigured to establish a secure bidirectional communication link between a blood glucose meter and insulin pump

ABSTRACT

A diabetes care kit for providing diagnostics and therapy that is preconfigured to reduce initial setup by a user. The kit can include a handheld diabetes managing device and insulin pump. The handheld diabetes managing device and insulin pump can each be preloaded with an encryption key such that the handheld diabetes managing device and the insulin pump are paired and a secure bidirectional communication link exists between the handheld diabetes managing device and the insulin pump.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application claims the benefit of U.S. Provisional Application No.61/393,562, filed on Oct. 15, 2010. The entire disclosure of the aboveapplication is incorporated herein by reference.

FIELD

The present disclosure relates generally to medical devices and moreparticularly to a simplified process for pairing a blood glucose meterand an insulin pump for secure and reliable wireless communication.

BACKGROUND

Medical devices are often used as diagnostic devices and/or therapeuticdevices in diagnosing and/or treating medical conditions of patients.For example, a blood glucose meter is used as a diagnostic device tomeasure blood glucose levels of patients suffering from diabetes. Aninsulin infusion pump is used as a therapeutic device to administerinsulin to patients suffering from diabetes.

Diabetes mellitus, often referred to as diabetes, is a chronic conditionin which a person has elevated blood glucose levels that result fromdefects in the body's ability to produce and/or use insulin. There arethree main types of diabetes. Type 1 diabetes can be autoimmune,genetic, and/or environmental and usually strikes children and youngadults. Type 2 diabetes accounts for 90-95% of diabetes cases and islinked to obesity and physical inactivity. Gestational diabetes is aform of glucose intolerance diagnosed during pregnancy and usuallyresolves spontaneously after delivery.

In 2009, according to the World Health Organization, at least 220million people worldwide suffer from diabetes. In 2005, an estimated 1.1million people died from diabetes. The incidence of diabetes isincreasing rapidly, and it is estimated that between 2005 and 2030, thenumber of deaths from diabetes will double. In the United States, nearly24 million Americans have diabetes, and an estimated 25% of seniors age60 and older are affected. The Centers for Disease Control andPrevention forecast that 1 in 3 Americans born after 2000 will developdiabetes during their lifetime. The National Diabetes InformationClearinghouse estimates that diabetes costs $132 billion in the UnitedStates alone every year. Without treatment, diabetes can lead to severecomplications such as heart disease, stroke, blindness, kidney failure,amputations, and death related to pneumonia and flu.

Diabetes is managed primarily by controlling the level of glucose in thebloodstream. This level is dynamic and complex, and is affected bymultiple factors including the amount and type of food consumed, and theamount of insulin (which mediates transport of glucose across cellmembranes) in the blood. Blood glucose levels are also sensitive toexercise, sleep, stress, smoking, travel, illness, menses, and otherpsychological and lifestyle factors unique to individual patients. Thedynamic nature of blood glucose and insulin, and all other factorsaffecting blood glucose, often require a person with diabetes toforecast blood glucose levels. Therefore, therapy in the form of insulinor oral medications, or both, can be timed to maintain blood glucoselevels in an appropriate range.

Management of diabetes is time-consuming for patients because of theneed to consistently obtain reliable diagnostic information, followprescribed therapy, and manage lifestyle on a daily basis. Diagnosticinformation, such blood glucose, is typically obtained from a capillaryblood sample with a lancing device and is then measured with a handheldblood glucose meter. Interstitial glucose levels may be obtained from acontinuous glucose sensor worn on the body. Prescribed therapies mayinclude insulin, oral medications, or both. Insulin can be deliveredwith a syringe, an ambulatory infusion pump, or a combination of both.With insulin therapy, determining the amount of insulin to be injectedcan require forecasting meal composition of fat, carbohydrates andproteins along with effects of exercise or other physiologic states. Themanagement of lifestyle factors such as body weight, diet, and exercisecan significantly influence the type and effectiveness of a therapy.

Management of diabetes involves large amounts of diagnostic data andprescriptive data acquired in a variety of ways: from medical devices,from personal healthcare devices, from patient-recorded logs, fromlaboratory tests, and from healthcare professional recommendations.Medical devices include patient-owned bG meters, continuous glucosemonitors, ambulatory insulin infusion pumps, diabetes analysis software,and diabetes device configuration software. Each of these systemsgenerates and/or manages large amounts of diagnostic and prescriptivedata. Personal healthcare devices include weight scales, blood pressurecuffs, exercise machines, thermometers, and weight management software.Patient recorded logs include information relating to meals, exerciseand lifestyle. Lab test results include HbAlC, cholesterol,triglycerides, and glucose tolerance. Healthcare professionalrecommendations include prescriptions, diets, test plans, and otherinformation relating to the patient's treatment.

There is a need for a handheld device to aggregate, manipulate, manage,present, and communicate diagnostic data and prescriptive data frommedical devices, personal healthcare devices, patient recordedinformation, biomarker information, and recorded information in anefficient manner. The handheld device can improve the care and health ofa person with diabetes so that the person with diabetes can lead a fulllife and reduce the risk of complications from diabetes.

Additionally, to effectively manage the care and health of the patient,there is a need for the handheld device to communicate with othermedical devices and systems. In order to communicate securely andreliably, the handheld device may need to establish a securecommunication link between itself and the other medical devices andsystems. Such a process may require a user (such as a patient withreduced visual acuity and/or technical skill) to follow a complexprocedure that requires extensive user input. Accordingly, there is aneed for a method of establishing a secure communication link betweenthe handheld device and other medical devices/systems that is relativelysimple and reduces the number and complexity of user inputs. Further,there is a need for a diabetes management system that reduces the numberand complexity of user inputs to utilize and establish a securecommunication link between various devices.

The background description provided herein is for the purpose ofgenerally presenting the context of the disclosure. Work of thepresently named inventors, to the extent it is described in thisbackground section, as well as aspects of the description that may nototherwise qualify as prior art at the time of filing, are neitherexpressly nor impliedly admitted as prior art against the presentdisclosure.

SUMMARY

According to the present disclosure, a diabetes care kit for providingdiagnostics and therapy that is preconfigured to reduce initial setup bya user is presented. The kit can include a handheld diabetes managingdevice and insulin pump. The handheld diabetes managing device and theinsulin pump can be paired such that a secure bidirectionalcommunication link exists between the handheld diabetes managing deviceand the insulin pump. The handheld diabetes managing device can includea blood glucose meter, a first processor, a first memory, a firstcommunication module and a first antenna. The blood glucose meter can beconfigured to determine a blood glucose level of a user. The firstprocessor can be coupled to the blood glucose meter. Additionally, thefirst processor can be configured to generate an insulin pump commandbased on the blood glucose level. The first memory can be coupled to theprocessor and can be preloaded with an encryption key. The firstcommunication module can coupled to the processor and first memory.Further, the first communication module can be configured to generate anencrypted communication message based on the insulin pump command andthe encryption key. The first antenna can be coupled to the firstcommunication module. The first antenna can also be configured totransmit the encrypted communication message.

The insulin pump can include an insulin dosing module, a secondprocessor, a second memory, a second communication module and a secondantenna. The insulin dosing module can be configured to dispense insulinbased on an insulin dose command. The second processor can be coupled tothe insulin dosing module. Further, the second processor can beconfigured to generate the insulin dose command based on the insulinpump command. The second memory can be coupled to the second processorand preloaded with the encryption key. The second communication modulecan be coupled to the second processor and the second memory.Additionally, the second communication module can be configured todecode the encrypted communication message based on the encryption keyto obtain the insulin pump command. The second antenna can be coupled tothe second communication module. The second antenna can also beconfigured to receive the encrypted communication message.

According to the present disclosure, a method of manufacturing adiabetes care kit for providing diagnostics and therapy that ispreconfigured to reduce initial setup by a user is presented. The methodcan include providing a handheld diabetes managing device, providing aninsulin pump, loading an encryption key in the handheld diabetesmanaging device and insulin pump and establishing a secure bidirectionalcommunication link between the handheld diabetes managing device and theinsulin pump by pairing the handheld diabetes managing device with theinsulin pump. The handheld diabetes managing device can include a bloodglucose meter configured to determine a blood glucose level of apatient, a first processor coupled to the blood glucose meter andconfigured to generate an insulin pump command based on the bloodglucose level, a first memory coupled to the first processor, a firstcommunication module coupled to the first processor and first memory andconfigured to generate an encrypted communication message based on theinsulin pump command, and a first antenna coupled to the firstcommunication module and configured to transmit the encryptedcommunication message. The insulin pump can include an insulin dosingmodule configured to dispense insulin to the patient based on an insulindose command, a second processor coupled to the insulin dosing moduleand configured to generate the insulin dose command based on the insulinpump command, a second memory coupled to the second processor, a secondcommunication module coupled to the second processor and the secondmemory and configured to decode the encrypted communication message toobtain the insulin pump command, and a second antenna coupled to thesecond communication module and configured to receive the encryptedcommunication message. The encryption key can be loaded in the first andsecond memory and be utilized to generate the encrypted communicationmessage at the handheld diabetes managing device and to decode theencrypted communication message at the insulin pump.

Further areas of applicability of the present disclosure will becomeapparent from the detailed description provided hereinafter. It shouldbe understood that the detailed description and specific examples areintended for purposes of illustration only and are not intended to limitthe scope of the disclosure.

BRIEF DESCRIPTION OF THE DRAWINGS

The present disclosure will become more fully understood from thedetailed description and the accompanying drawings, wherein:

FIG. 1 shows a patient and a treating clinician;

FIG. 2 shows a patient with a continuous glucose monitor (CGM),ambulatory durable insulin infusion pump, ambulatory non-durable insulininfusion pump, and diabetes manger;

FIG. 3 shows a diabetes care system of systems used by patients andclinicians to manage diabetes;

FIG. 4 shows a flow-chart illustrating a portion of an exemplary methodof pairing a handheld diabetes managing device and an insulin pumpaccording to the present disclosure;

FIG. 5 shows a flow-chart illustrating a portion of an exemplary methodof pairing a handheld diabetes managing device and an insulin pumpaccording to the present disclosure;

FIG. 6 shows a flow-chart illustrating a portion of an exemplary methodof pairing a handheld diabetes managing device and an insulin pumpaccording to the present disclosure;

FIG. 7A shows a flow-chart illustrating a portion of an exemplary methodof pairing a handheld diabetes managing device and an insulin pumpaccording to the present disclosure;

FIG. 7B shows a flow-chart illustrating a portion of an exemplary methodof pairing a handheld diabetes managing device and an insulin pumpaccording to the present disclosure;

FIG. 8A shows a flow-chart illustrating a portion of an exemplary methodof pairing a handheld diabetes managing device and an insulin pumpaccording to the present disclosure;

FIG. 8B shows a flow-chart illustrating a portion of an exemplary methodof pairing a handheld diabetes managing device and an insulin pumpaccording to the present disclosure;

FIG. 9 shows a flow-chart illustrating an exemplary method ofestablishing a secure bidirectional communication link during pairing ofa handheld diabetes managing device and an insulin pump according to thepresent disclosure;

FIG. 10 shows a flow-chart illustrating an exemplary method ofconfirming receipt of a communication message by a receiving deviceaccording to the present disclosure;

FIG. 11 shows a flow-chart illustrating an exemplary method ofauthenticating a communication message sent from a transmitting deviceto a receiving device according to the present disclosure;

FIG. 12 shows an exemplary diabetes care kit for providing diagnosticsand therapy according to the present disclosure;

FIG. 13 shows a block diagram of an exemplary handheld diabetes managingdevice according to the present disclosure; and

FIG. 14 shows a block diagram of an exemplary insulin pump according tothe present disclosure.

DETAILED DESCRIPTION

Referring now to FIG. 1, a person 100 with diabetes and a healthcareprofessional 102 are shown in a clinical environment. Persons withdiabetes include persons with metabolic syndrome, pre-diabetes, type 1diabetics, type 2 diabetics, and gestational diabetics and arecollectively referred to as a patient. Healthcare providers for diabetesare diverse and include nurses, nurse practitioners, physicians, andendocrinologists and are collectively referred to as a clinician.

During a healthcare consultation, the patient 100 typically shares withthe clinician 102 a variety of patient data including blood glucosemeasurements, continuous glucose monitor data, amounts of insulininfused, amounts of food and beverages consumed, exercise schedules, andother lifestyle information. The clinician 102 can obtain additionalpatient data that includes measurements of HbAlC, cholesterol levels,triglycerides, blood pressure, and weight of the patient 100. Thepatient data can be recorded manually or electronically on a handhelddiabetes management device 104, a diabetes analysis software executed ona personal computer (PC) 106, and/or a web-based diabetes analysis site(not shown). The clinician 102 can analyze the patient data manually orelectronically using the diabetes analysis software and/or the web-baseddiabetes analysis site. After analyzing the patient data and reviewingadherence of the patient 100 to previously prescribed therapy, theclinician 102 can decide whether to modify the therapy for the patient100.

Referring now to FIG. 2, the patient 100 can use a continuous glucosemonitor (CGM) 200, an ambulatory durable insulin infusion pump 202 or anambulatory non-durable insulin infusion pump 204 (collectively insulinpump 202 or 204), and the handheld diabetes management device 104(hereinafter the diabetes manager 104). The CGM 200 uses a subcutaneoussensor to sense and monitor the amount of glucose in the blood of thepatient 100 and communicates corresponding readings to the handhelddiabetes management device 104.

The diabetes manager 104 performs various tasks including measuring andrecording blood glucose levels, determining an amount of insulin to beadministered to the patient 100 via the insulin pump 202 or 204,receiving patient data via a user interface, archiving the patient data,etc. The diabetes manager 104 periodically receives readings from theCGM 200 indicating insulin level in the blood of the patient 100. Thediabetes manager 104 transmits instructions to the insulin pump 202 or204, which delivers insulin to the patient 100. Insulin can be deliveredin the form of a bolus dose, which raises the amount of insulin in theblood of the patient 100 by a predetermined amount. Additionally,insulin can be delivered in a scheduled manner in the form of a basaldose, which maintains a predetermined insulin level in the blood of thepatient 100.

Referring now to FIG. 3, a diabetes management system 300 used by thepatient 100 and the clinician 102 includes one or more of the followingdevices: the diabetes manager 104, the continuous glucose monitor (CGM)200, the insulin pump 202 or 204, a mobile device 302, the diabetesanalysis software on the PC 106, and other healthcare devices 304. Thediabetes manager 104 is configured as a system hub and communicates withthe devices of the diabetes management system 300. Alternatively, theinsulin pump 204 or the mobile device 302 can serve as the system hub.Communication between the various devices in the diabetes managementsystem 300 can be performed using wireless interfaces (e.g., Bluetooth)and/or wireline interfaces (e.g., USB). Communication protocols used bythese devices can include protocols compliant with the IEEE 11073standard as extended using guidelines provided by Continua® HealthAlliance Design Guidelines. Further, healthcare records systems such asMicrosoft® HealthVault™ and Google™ Health can be used by the patient100 and clinician 102 to exchange information.

The diabetes manager 104 can receive blood glucose readings from one ormore sources (e.g., from the CGM 200). The CGM 200 continuously measuresthe blood glucose level of the patient 100. The CGM 200 periodicallycommunicates the blood glucose level to the diabetes manager 104. Thediabetes manager 104 and the CGM 200 communicate wirelessly using aproprietary Gazell wireless protocol developed by Nordic Semiconductor,Inc. or any other wireless protocol (Bluetooth Low Energy, etc.).

Additionally, the diabetes manager 104 includes a blood glucose meter(BGM) and a port that communicates with the BGM (both not shown). Theport can receive a blood glucose measurement strip 306. The patient 100deposits a sample of blood or other bodily fluid on the blood glucosemeasurement strip 306. The BGM analyzes the sample and measures theblood glucose level in the sample. The blood glucose level measured fromthe sample and/or the blood glucose level read by the CGM 200 can beused to determine the amount of insulin to be administered to thepatient 100.

The diabetes manager 104 communicates with the insulin pump 202 or 204.The insulin pump 202 or 204 can be configured to receive instructionsfrom the diabetes manager 104 to deliver a predetermined amount ofinsulin to the patient 100. Additionally, the insulin pump 202 or 204can receive other information including meal and/or exercise schedulesof the patient 100. The insulin pump 202 or 204 can determine the amountof insulin to administer based on the additional information.

The insulin pump 202 or 204 can also communicate data to the diabetesmanager 104. The data can include amounts of insulin delivered to thepatient 100, corresponding times of delivery, and pump status. Thediabetes manager 104 and the insulin pump 202 or 204 can communicateusing a wireless communication protocol such as Bluetooth. Otherwireless or wireline communication protocols can also be used.

In addition, the diabetes manager 104 can communicate with otherhealthcare devices 304. For example, the other healthcare devices 304can include a blood pressure meter, a weight scale, a pedometer, afingertip pulse oximeter, a thermometer, etc. The other healthcaredevices 304 obtain and communicate personal health information of thepatient 100 to the diabetes manager 104 through wireless, USB, or otherinterfaces. The other healthcare devices 304 use communication protocolscompliant with ISO/IEEE 11073 extended using guidelines from Continual®Health Alliance. The diabetes manager 104 can communicate with the otherhealthcare devices 304 using interfaces including Bluetooth, USB, etc.Further, the devices of the diabetes management system 300 cancommunicate with each other via the diabetes manager 104.

The diabetes manager 104 can communicate with the PC 106 usingBluetooth, USB, or other interfaces. A diabetes management softwarerunning on the PC 106 includes an analyzer-configurator that storesconfiguration information of the devices of the diabetes managementsystem 300. The configurator has a database to store configurationinformation of the diabetes manager 104 and the other devices. Theconfigurator can communicate with users through standard web or computerscreens in non-web applications. The configurator transmitsuser-approved configurations to the devices of the diabetes managementsystem 300. The analyzer retrieves data from the diabetes manager 104,stores the data in a database, and outputs analysis results throughstandard web pages or computer screens in non-web based applications.

The diabetes manager 104 can communicate with the mobile device 302using Bluetooth. The mobile device 302 can include a cellular phone, aPDA, or a pager. The diabetes manager 104 can send messages to anexternal network through the mobile device 302. The mobile device 302can transmit messages to the external network based on requests receivedfrom the diabetes manager 104.

In some embodiments, the communication between the diabetes manager 104and the insulin pump 202 or 204 can be made more secure and reliable byincluding various security features. When the diabetes manager 104 andthe insulin pump 202 or 204 will communicate wirelessly, for example,the diabetes manager 104 and the insulin pump 202 or 204 can be pairedto establish a secure bidirectional communication link. Variousexemplary methods of pairing a handheld diabetes managing device (suchas diabetes manager 104) and an insulin pump (such as insulin pump 202or 204) are illustrated in FIGS. 4-10.

Referring now to FIGS. 4 and 5, a first exemplary method 400 of pairinga handheld diabetes managing device and an insulin pump according to thepresent disclosure illustrated. While each step in the exemplary method400 is illustrated and will be described herein as occurring at one ofthe handheld diabetes managing device or the insulin pump, one skilledin the art will appreciate that each step could occur at the other one,or both, of the handheld diabetes managing device or the insulin pump.For example only, method 400 begins at step 402 with the pairingprocedure being initiated at the diabetes managing device and proceedsto step 404 with the insulin pump displaying “Initiate PairingProcedure?” on an insulin pump display. One skilled in the art willrecognize that the pairing procedure can instead be initiated at theinsulin device and the diabetes managing device can display “InitiatePairing Procedure?” on a diabetes managing device display.

Method 400 begins at step 402 with the pairing procedure being initiatedat the diabetes managing device. The method proceeds to step 404 atwhich the insulin pump displays “Initiate Pairing Procedure?” on aninsulin pump display. At step 406, the pairing procedure is initiated atthe insulin pump. The pairing procedure can be initiated by placing thediabetes managing device and/or insulin pump in a “pairing” mode, forexample, by a switch or push button. In some embodiments, a user, suchas the patient 100 or clinician 102 described above, can initiate thepairing procedure, for example, by selecting an “Initiate PairingProcedure?” option from a dropdown menu on the diabetes managing deviceand/or insulin pump or by choosing “Yes” or similar when prompted by“Initiate Pairing Procedure?” on the display. In some embodiments, thediabetes managing device display and/or the insulin pump display can bea touchscreen that allows a user to touch an appropriate location on thedisplay to initiate the pairing procedure.

At step 410, the diabetes managing device searches for a pumpidentification signal, which is output from the insulin pump at step408. The pump identification signal can include a pump identificationcode that contains information sufficient to uniquely identify theinsulin pump, for example, the brand name, model and/or serial number.The diabetes managing device receives the pump identification signal atstep 412 and obtains the pump identification code from the pumpidentification signal at step 414. The pump identification code can thenbe displayed on the diabetes managing device display (step 416). In someembodiments, the diabetes managing device can display information (suchas a pump identification code) related to any and all insulin pumps thatare within the communication range of the diabetes managing device.

In order to ensure that the proper pump identification code is selected,the insulin pump can display its unique pump identification code on itsdisplay (step 418). The user (patient 100, clinician 102, etc.) can thenchoose the pump identification code on the diabetes managing device thatmatches the pump identification code displayed on the insulin pump. Inthis manner, the proper pump identification code can be selected suchthat the diabetes managing device receives an insulin pump selectioninput at step 420. The insulin pump can search for an insulin pumpselection confirmation signal (step 422), which is output from thediabetes managing device at step 424. At step 426, the insulin pumpselection confirmation signal is received by the insulin pump to informthe insulin pump that it has been selected by the diabetes managingdevice for pairing.

The method 400 continues, as shown in FIG. 5, to steps 428 and 430 atwhich the diabetes managing device and insulin pump generate first andsecond verification strings, respectively. The first verification stringcan be displayed on the diabetes managing device display (step 432) andthe second verification string can be displayed on the insulin pumpdisplay (step 434). If the first and second verification strings match,the diabetes managing device can receive a first confirmation input atstep 436. Similarly, the insulin pump can receive a second confirmationinput at step 438 if the first and second verification strings match.

In some embodiments, the user (patient 100, clinician 102, etc.) canconfirm that first and second verification strings match and input thefirst and second confirmation inputs into the diabetes managing deviceand insulin pump, respectively. The user can input the first and secondconfirmation inputs, for example, by actuating a switch or push button,selecting an appropriate option from a dropdown menu on the diabetesmanaging device and/or insulin pump or by selecting “Match” or similaroption on the diabetes managing device and/or insulin pump displays. Insome embodiments, the diabetes managing device display and/or theinsulin pump display can be touch screens that allows a user to touch anappropriate location on the display to input the first and secondconfirmation inputs. For example only, the diabetes managing device(diabetes manager 104) can have a touch screen display that displays thefirst verification string, a message reading “Does this code match thecode on the insulin pump you are attempting to pair?” and two softbuttons—one reading “Yes” and the other “No.” Similarly, the insulinpump can have a touch screen display that displays the secondverification string, a message reading “Does this code match the code onthe diabetes manager you are attempting to pair?” and two softbuttons—one reading “Yes” and the other “No.” In this example, the usercan input the first and second confirmation inputs into the diabetesmanaging device and insulin pump, respectively, by activating one of thesoft buttons by touching the touch screen at the appropriate location.

Upon receipt of the first confirmation input at the diabetes managingdevice and the second confirmation input at the insulin pump, a securebidirectional communication link is established at steps 440 and 442 tocomplete the pairing procedure, after which method 400 ends. If thefirst and second verification strings do not match, however, the pairingprocedure can terminate (or be terminated by the user) without pairingthe diabetes managing device and insulin pump.

In order to provide further security, the first and second verificationstrings can be independently generated by the diabetes managing deviceand insulin pump, respectively. In some embodiments, further describedbelow, the first and second verification strings can be generated by analgorithm that is performed at each of the diabetes managing device andinsulin pump. An input (for example, an encryption key) can be generatedat one of the diabetes managing device and insulin pump and transmittedto the other one of the diabetes managing device and insulin pump. Forexample only, the input can be generated by a random number generator orsimilar device, or the input may be selected from a list of all possibleinputs, e.g., based on output of a random number generator or similar.This input can be utilized by the algorithm to generate the first andsecond verification strings. In this manner, the first and secondverification strings are not transmitted between the diabetes managingdevice and the insulin pump and, thus, are not subject to beingintercepted and used to pair an unauthorized device with the diabetesmanaging device or insulin pump.

Referring now to FIGS. 4 and 6, a second exemplary method 500 of pairinga handheld diabetes managing device and an insulin pump according to thepresent disclosure illustrated. Method 500 is similar to method 400 andcan include one, more or all of steps 402 to 426 described above.

After the diabetes managing device outputs the insulin pump selectionconfirmation signal at step 424 and the insulin pump receives theinsulin pump confirmation signal at step 426 (FIG. 4), method 500proceeds to step 502 as shown in FIG. 6. At step 502 the diabetesmanaging device generates a first encryption key. For example only, thefirst encryption key can be a public RSA key that can be used with theRSA algorithm, a well-known public-key cryptography algorithm, however,it is possible that any type of encryption key can be utilized with thepresent disclosure. The diabetes managing device can then output a firstencryption signal that contains the first encryption key at step 504. Atstep 506, the insulin pump can receive the first encryption signal andobtain the first encryption key from the first encryption signal at step508.

Based on and utilizing the first encryption key, the diabetes managingdevice (step 510) and the insulin pump (step 512) can generate the firstand second verification strings, respectively. As described above, thefirst encryption key can be input to or otherwise utilized by thealgorithm stored at both the diabetes managing device and the insulinpump to independently generate the first and second verificationstrings. At step 514, the first verification string can be displayed onthe diabetes managing device display. Similarly, at step 516 the secondverification string can be displayed on the insulin pump display. If thefirst and second verification strings match, the diabetes managingdevice can receive a first confirmation input at step 518 and theinsulin pump can receive a second confirmation input at step 520. Insome embodiments, the user (patient 100, clinician 102, etc.) canconfirm that first and second verification strings match and input thefirst and second confirmation inputs into the diabetes managing deviceand insulin pump, respectively.

Upon receipt of the first confirmation input at the diabetes managingdevice and the second confirmation input at the insulin pump, a securebidirectional communication link is established at steps 522 and 524 tocomplete the pairing procedure, after which method 500 ends. If thefirst and second verification strings do not match, however, the pairingprocedure can terminate (or be terminated by the user) without pairingthe diabetes managing device and insulin pump.

Referring now to FIGS. 4, 7A and 7B, a third exemplary method 600 ofpairing a handheld diabetes managing device and an insulin pumpaccording to the present disclosure illustrated. Method 600 is similarto methods 400 and 500 and can include one, more or all of steps 402 to426 described above.

After the diabetes managing device outputs the insulin pump selectionconfirmation signal at step 424 and the insulin pump receives theinsulin pump confirmation signal at step 426 (FIG. 4), method 600proceeds to step 602 as shown in FIG. 7A. At step 602 the diabetesmanaging device generates a first encryption key. For example only, thefirst encryption key can be a public RSA key that can be used with theRSA algorithm, a well-known public-key cryptography algorithm, however,it is possible that any type of encryption key can be utilized with thepresent disclosure. The diabetes managing device can then output a firstencryption signal that contains the first encryption key at step 604. Atstep 606, the insulin pump can receive the first encryption signal andobtain the first encryption key from the first encryption signal at step608.

After obtaining the first encryption key at step 608, the insulin pumpcan generate a second encryption key (step 610) and generate a secondencryption key message that contains the second encryption key (step612). For example only, the first and second encryption keys can each bea public RSA key, however, it is possible that any type of encryptionkey can be utilized with the present disclosure. At step 614, theinsulin pump encrypts the second encryption key message (that includesthe second encryption key) based on and utilizing the first encryptionkey to generate a second encryption signal. The insulin pump thenoutputs the second encryption signal at step 616.

After outputting the first encryption signal, the diabetes managingdevice can search for the second encryption signal at step 618. Thediabetes managing device can receive the second encryption signal (step620) and obtain the second encryption key from the second encryptionsignal (step 622). In various embodiments, the diabetes managing devicecan obtain the second encryption key by decoding the second encryptionsignal with the first encryption key, which was generated at step 602.

Based on and utilizing the second encryption key, the diabetes managingdevice (step 624) and the insulin pump (step 626) can generate the firstand second verification strings, respectively. Similar to the processdescribed above in regard to the first encryption key, the secondencryption key can be input to or otherwise utilized by an algorithmstored at both the diabetes managing device and the insulin pump toindependently generate the first and second verification strings.Referring now to FIG. 7B, the first verification string can be displayedon the diabetes managing device display at step 628. Similarly, at step630 the second verification string can be displayed on the insulin pumpdisplay. If the first and second verification strings match, thediabetes managing device can receive a first confirmation input (step632) and the insulin pump can receive a second confirmation input (step634). In some embodiments, the user (patient 100, clinician 102, etc.)can confirm that first and second verification strings match and inputthe first and second confirmation inputs into the diabetes managingdevice and insulin pump, respectively.

Upon receipt of the first confirmation input at the diabetes managingdevice and the second confirmation input at the insulin pump, a securebidirectional communication link is established at steps 636 and 638 tocomplete the pairing procedure, after which method 600 ends. If thefirst and second verification strings do not match, however, the pairingprocedure can terminate (or be terminated by the user) without pairingthe diabetes managing device and insulin pump.

Referring now to FIGS. 4, 8A and 8B, a fourth exemplary method 700 ofpairing a handheld diabetes managing device and an insulin pumpaccording to the present disclosure illustrated. Method 700 is similarto methods 400, 500 and 600 and can include one, more or all of steps402 to 426 described above.

After the diabetes managing device outputs the insulin pump selectionconfirmation signal at step 424 and the insulin pump receives theinsulin pump confirmation signal at step 426 (FIG. 4), method 700proceeds to step 702 as shown in FIG. 8A. At step 702 the diabetesmanaging device generates a first encryption key. For example only, thefirst encryption key can be a public RSA key that can be used with theRSA algorithm, a well-known public-key cryptography algorithm, however,it is possible that any type of encryption key can be utilized with thepresent disclosure. The diabetes managing device can then output a firstencryption signal that contains the first encryption key at step 704. Atstep 706, the insulin pump can receive the first encryption signal andobtain the first encryption key from the first encryption signal at step708.

After obtaining the first encryption key at step 708, the insulin pumpcan generate a second encryption key (step 710) and generate a secondencryption key message that contains the second encryption key (step712). For example only, the first and second encryption keys can each bea public RSA key, however, it is possible that any type of encryptionkey can be utilized with the present disclosure. At step 714, theinsulin pump encrypts the second encryption key message (that includesthe second encryption key) based on and utilizing the first encryptionkey to generate a second encryption signal. The insulin pump thenoutputs the second encryption signal at step 716.

After outputting the first encryption signal, the diabetes managingdevice can search for the second encryption signal at step 718. Thediabetes managing device can receive the second encryption signal (step720) and obtain the second encryption key from the second encryptionsignal (step 722). In various embodiments, the diabetes managing devicecan obtain the second encryption key by decoding the second encryptionsignal with the first encryption key, which was generated at step 702.

Based on and utilizing the second encryption key, both the diabetesmanaging device (step 724) and the insulin pump (step 726) can generatea third encryption key. Similar to the process described above in regardto the generation of the first and second verification strings based onthe second encryption key, the second encryption can be input to orotherwise utilized by an algorithm stored at both the diabetes managingdevice and the insulin pump to independently generate the thirdencryption key. For example only, the first encryption key can be aTwofish cipher key that can be used with the Twofish algorithm, awell-known cryptography algorithm.

Referring now to FIG. 8B, based on and utilizing the third encryptionkey, the diabetes managing device (step 728) and the insulin pump (step730) can generate the first and second verification strings,respectively. Similar to the process described above in regard to thefirst and second encryption keys, the third encryption can be input toor otherwise utilized by the algorithm stored at both the diabetesmanaging device and the insulin pump to independently generate the firstand second verification strings. The first verification string can bedisplayed on the diabetes managing device display at step 732.Similarly, at step 734 the second verification string can be displayedon the insulin pump display. If the first and second verificationstrings match, the diabetes managing device can receive a firstconfirmation input (step 736) and the insulin pump can receive a secondconfirmation input (step 738). In some embodiments, the user (patient100, clinician 102, etc.) can confirm that first and second verificationstrings match and input the first and second confirmation inputs intothe diabetes managing device and insulin pump, respectively.

Upon receipt of the first confirmation input at the diabetes managingdevice and the second confirmation input at the insulin pump, a securebidirectional communication link is established at steps 740 and 742 tocomplete the pairing procedure, after which method 700 ends. If thefirst and second verification strings do not match, however, the pairingprocedure can terminate (or be terminated by the user) without pairingthe diabetes managing device and insulin pump.

Referring now to FIG. 9, an exemplary method 800 of establishing asecure bidirectional communication link during pairing of a handhelddiabetes managing device and an insulin pump according to the presentdisclosure is illustrated. Method 800 can be utilized, for example, atsteps 440, 442, 522, 524, 636, 638, 740 and 742 described above. In FIG.9, method 800 is illustrated as taking place at a transmitting deviceand a receiving device. One skilled in the art will appreciate that thediabetes managing device (such as diabetes manager 104) and insulin pump(such as insulin pump 202 or 204) described above can act as either oneof the transmitting device or the receiving device. That is, thediabetes managing device can act as the transmitting device and theinsulin pump can act as the receiving device, or the insulin pump canact as the transmitting device and the diabetes managing device can actas the receiving device.

The method 800 begins at step 802 at which the transmitting devicegenerates a test communication message. At step 804, the transmittingdevice then encrypts the test communication message with an encryptionkey to generate an encrypted test communication message. The encryptionkey can be any type of encryption key, including but not limited to thefirst, second or third encryption key described above. The encryptedtest communication message is output by the transmitting device at step806 and received by the receiving device at step 808. The receivingdevice then decodes the encrypted test communication message with theencryption key to obtain the test communication message (step 810). Invarious embodiments, the test communication message can beauthenticated, as described below with reference to FIG. 11. Thereceiving device then confirms receipt of the test communication message(step 812) and stores the encryption key (step 814) for future use.

After outputting the encrypted test communication message, thetransmitting device searches for confirmation of receipt of the testcommunication message by the receiving device (step 816). At step 818,the transmitting device receives confirmation of receipt of the testcommunication message by the receiving device. The encryption key isstored at the transmitting device for future use at step 820, afterwhich method 800 ends.

Referring now to FIG. 10, an exemplary method 850 of confirming receiptof a test communication message by a receiving device according to thepresent disclosure illustrated. Method 850 can be utilized, for example,at step 812, 816 and 818 described above. In FIG. 10, method 850 isillustrated as taking place at a transmitting device and a receivingdevice. One skilled in the art will appreciate that the diabetesmanaging device (such as diabetes manager 104) and insulin pump (such asinsulin pump 202 or 204) described above can act as either one of thetransmitting device or the receiving device. That is, the diabetesmanaging device can act as the transmitting device and the insulin pumpcan act as the receiving device, or the insulin pump can act as thetransmitting device and the diabetes managing device can act as thereceiving device.

The method 850 begins at step 852 at which the receiving devicegenerates a test communication received message. At step 854, thereceiving device then encrypts the test communication received messagewith an encryption key to generate an encrypted test communicationreceived message. The encryption key can be any type of encryption key,including but not limited to the first, second or third encryption keydescribed above. The encrypted test communication received message isoutput by the received device at step 856.

At step 858, the transmitting device searches for the encrypted testcommunication received message output by the receiving device at step856. The encrypted test communication received message is received bythe transmitting device at step 860. The transmitting device thendecodes the encrypted test communication received message with theencryption key at step 862, after which method 850 ends. While method850 of FIG. 10 has been described in the context of confirming receiptof a test communication message by a receiving device, one skilled inthe art will appreciate that method 850 can be utilized to confirmreceipt of any, some or all communication messages sent between thetransmitting and receiving devices.

Referring now to FIG. 11, an exemplary method 900 of authenticating acommunication message sent from a transmitting device to a receivingdevice according to the present disclosure illustrated. Method 900 canbe utilized, for example, to authenticate the test communication messagedescribed above in relation to FIGS. 9 and 10. In various embodiments,method 900 can be used to authenticate each and every communicationmessage sent from the transmitting device to the receiving device.

In FIG. 11, method 900 is illustrated as taking place at a transmittingdevice and a receiving device. One skilled in the art will appreciatethat the diabetes managing device (such as diabetes manager 104) andinsulin pump (such as insulin pump 202 or 204) described above can actas either one of the transmitting device or the receiving device. Thatis, the diabetes managing device can act as the transmitting device andthe insulin pump can act as the receiving device, or the insulin pumpcan act as the transmitting device and the diabetes managing device canact as the receiving device.

The method 900 begins at step 902 at which the transmitting devicegenerates a first message authentication code based on the communicationmessage and the encryption key. The first message authentication codecan be generated by a process that is similar to the process describedabove in regard to the generation of the first and second verificationstrings. For example only, the first message authentication code can begenerated based on inputting the communication message and theencryption key to an algorithm stored at both the diabetes managingdevice and the insulin pump. The encryption key can be any type ofencryption key, including but not limited to the first, second or thirdencryption key described above. At step 904, the transmitting deviceincludes the first message authentication code in an encryptedcommunication message. The encrypted communication message can include aversion of the communication message that has been encrypted with theencryption key, as well as the first message authentication codegenerate at step 902. For example only, the encrypted communicationmessage can include two separate data fields; the first data field caninclude the communication message that has been encrypted and the seconddata field can include the first message authentication code.

The transmitting device outputs the encrypted communication message atstep 906, which is received by the receiving device at step 908. Thereceiving device decodes the encrypted communication message at step 910to obtain the communication message and the first message authenticationcode. At step 912, the receiving device can generate a second messageauthentication code based on the communication message and encryptionkey. The second message authentication code can be generated by the sameprocess used to generate the first message authentication code describedabove, i.e., the second message authentication code can be generated byinputting the communication message and the encryption key to thealgorithm stored at both the diabetes managing device and the insulinpump. If the diabetes managing device and the insulin pump both sharethe same algorithm and encryption key, each communication message may beauthenticated by comparing the first and second message authenticationcodes. Thus, the receiving device compares the first and second messageauthentication codes at step 914. If the first and second messageauthentication codes do not match, the method 900 proceeds to step 916at which the receiving device disregards the encrypted communicationmessage as inauthentic. If, however, the first and second messageauthentication codes do match, the method 900 proceeds to step 918 atwhich the receiving device accepts the encrypted communication messageas authentic. After either step 916 or 918, method 900 ends.

Referring now to FIGS. 12-14, a diabetes care kit 950 for providingdiagnostics and therapy according to the present disclosure isillustrated. Diabetes care kit 950 can include a handheld diabetesmanaging device (such as diabetes manager 104) and an insulin pump (suchas insulin pump 202 or 204). Diabetes care kit 950 can be preconfiguredto reduce initial setup by a user (patient 100, clinician 102, etc.),for example, by establishing a paired relationship between the diabetesmanager 104 and insulin pump 204 before providing the diabetes care kit950 to the user.

Referring now to FIG. 13, diabetes manager 104 can include a bloodglucose meter 1041, a first processor 1043, a first memory 1045, a firstcommunication module 1047 and a first antenna 1049. The blood glucosemeter 1041 can determine a blood glucose level of a user, for example,by measuring the blood glucose in a capillary blood sample provided bythe user or obtaining a blood glucose estimate provided by a continuousglucose monitor, such as CGM 200 described above. The blood glucosemeter 1041 can be coupled to the first processor 1043 such that thefirst processor 1043 can receive the blood glucose level from the bloodglucose meter 1041. Based on the blood glucose level, the firstprocessor 1043 can generate an insulin pump command. The insulin pumpcommand can be an instruction that notifies the insulin pump 204 toprovide an appropriate dose of insulin to provide to the user. The firstprocessor 1043 can generate the insulin pump command based on analgorithm stored in the first memory 1045. In addition to the bloodglucose level of the user, the insulin pump command can be based on anumber of other factors, such as the weight and insulin resistance ofthe user, and input(s) by the user regarding whether the user will beeating a meal or exercising.

An encryption key can also be preloaded into the first memory 1045 foruse by the first processor 1043 and first communication module 1047. Forexample only, the encryption key can be loaded into the first memory1045 during manufacture of the diabetes manager 104, after completion ofmanufacture but before the diabetes manager 104 is packaged or otherwiseincluded in the kit 950, or any time before providing the kit 950 to auser. The encryption key (such as the first, second or third encryptionkey described above) can be utilized to establish a secure bidirectionalcommunication link between the diabetes manager 104 and insulin pump 204as well as for other security purposes (such as authentication ofmessages transmitted between the diabetes manager 104 and insulin pump204), as described above.

The first communication module 1047 can be coupled to the firstprocessor 1043 and first memory 1047. The first communication module1047 can utilize the encryption key to generate encrypted communicationmessages, such as an encrypted communication message based on theinsulin pump command. The first antenna 1049 can be coupled to the firstcommunication module 1047 such that encrypted communication messages canbe transmitted from the first antenna 1049 to, e.g., the insulin pump204.

Referring now to FIG. 14, insulin pump 204 can include an insulin dosingmodule 2041, a second processor 2043, a second memory 2045, a secondcommunication module 2047 and a second antenna 2049. The insulin dosingmodule 2041 can dispense insulin to a user (patient 100) based on theinsulin pump command. The insulin dosing module 2041 can be coupled tothe second processor 2043 such that the second processor 1043 cantransmit an insulin dose command to the insulin dosing module 2041. Theinsulin dose command can be generated by the second processor 2043 basedon the insulin pump command. An algorithm stored in the second memory2045 can be utilized by the processor 2043 to generate the insulin dosecommand. In addition to the insulin pump command, the insulin dosecommand can be based on a number of other factors, such as a previousdose or doses provided to the user or a blood glucose estimate providedby a continuous glucose monitor, such as CGM 200 described above.

The encryption key can also be preloaded into the second memory 2045 foruse by the second processor 2043 and second communication module 2047.For example only, the encryption key can be loaded into the secondmemory 2045 during manufacture of the insulin pump 204, after completionof manufacture but before the insulin pump 204 is packaged or otherwiseincluded in the kit 950, or any time before providing the kit 950 to auser. The encryption key (such as the first, second or third encryptionkey described above) can be utilized to establish a secure bidirectionalcommunication link between the diabetes manager 104 and insulin pump 204as well as for other security purposes (such as authentication ofmessages transmitted between the diabetes manager 104 and insulin pump204), as described above.

The second antenna 2049 can be coupled to the second communicationmodule 2047. The second antenna 2049 can decode encrypted communicationmessages sent by the diabetes manager 104, such as the encryptedcommunication message based on the insulin pump command. The secondcommunication module 2047 can be coupled to the second antenna 2049, aswell as the second processor 2043 and second memory 2047. The secondcommunication module 2047 can utilize the encryption key to decode theencrypted communication messages sent by the diabetes manager 104. Forexample, the second communication module 1047 can utilize the encryptionkey to decode the encrypted communication message to obtain the insulinpump command generated by the diabetes manager 104.

While the diabetes manager 104 has been described above as generatingand transmitting encrypted communication messages to the insulin pump204, and the insulin pump has been described as receiving and decodingencrypted communication messages from the diabetes manager 104, oneskilled in the art will appreciate that the diabetes manager 104 canalso receive and decode encrypted communication messages generated byand transmitted from the insulin pump 204.

Furthermore, the kit 950 and its associated diabetes manager 104 andinsulin pump 204 can perform the methods described above in relation toFIGS. 4-11, such as, but not limited to, any or all of the methods 400,500, 600, 700, 850, 900 for pairing and utilizing a secure bidirectionalcommunication link between the diabetes manager 104 and insulin pump204, any or all of the methods 800, 850 for establishing the securebidirectional communication link by sending a test communication messagefrom the diabetes manager 104 to the insulin pump 204 (or vice-versa)and confirming receipt of communication messages sent from the diabetesmanager 104 to the insulin pump 204 (or vice-versa), and the method 900of method of authenticating a communication message sent from thediabetes manager 104 to the insulin pump 204 (or vice-versa). Forexample, the kit 950 and its associated diabetes manager 104 and insulinpump 204 can perform the methods of pairing and utilizing a securebidirectional communication link, as described above, in the event thata user replaces a component of, or adds a component (such as, CGM 200)to, the kit 950 after obtaining the kit 950.

In some exemplary embodiments, the handheld diabetes managing device(diabetes manager 104) can include a first pairing application. Thefirst pairing application can be implemented as computer executableinstructions stored on a non-transitory tangible computer readablemedium at the handheld diabetes managing device, such as first memory1045. The first pairing application can be configured to execute apairing procedure at the handheld diabetes managing device (diabetesmanager 104) for pairing the handheld diabetes managing device (diabetesmanager 104) and the insulin pump (insulin pump 204). Similarly, theinsulin pump (insulin pump 204) can include a second pairingapplication. The second pairing application can be implemented ascomputer executable instructions stored on a non-transitory tangiblecomputer readable medium at the insulin pump, such as second memory2045. The second pairing application can be configured to execute thepairing procedure at the insulin pump (insulin pump 204). The pairingprocedure can include, for example, any or all of the methods 400, 500,600, 700, 800, 850, 900 for pairing and utilizing a secure bidirectionalcommunication link between the diabetes manager 104 and insulin pump 204that are described above.

In some exemplary embodiments, the handheld diabetes managing device(diabetes manager 104) can include a first message confirmationapplication. The first message confirmation application can beimplemented as computer executable instructions stored on anon-transitory tangible computer readable medium at the handhelddiabetes managing device, such as first memory 1045. The first messageconfirmation application can be configured to execute a procedure at thehandheld diabetes managing device (diabetes manager 104) for confirmingreceipt of a communication message at a receiving device, such as thehandheld diabetes managing device (diabetes manager 104) and/or theinsulin pump (insulin pump 204). Similarly, the insulin pump (insulinpump 204) can include a second message confirmation application. Thesecond message confirmation application can be implemented as computerexecutable instructions stored on a non-transitory tangible computerreadable medium at the insulin pump, such as second memory 2045. Thesecond message confirmation application can be configured to execute theprocedure for confirming receipt of the communication message at thereceiving device at the insulin pump (insulin pump 204). The procedurecan include, for example, any or all of the methods 800, 850 forconfirming receipt of the communication message at the diabetes manager104 and/or insulin pump 204 that are described above.

Finally, in various exemplary embodiments, the handheld diabetesmanaging device (diabetes manager 104) can include a first messageauthentication application. The first message authentication applicationcan be implemented as computer executable instructions stored on anon-transitory tangible computer readable medium at the handhelddiabetes managing device, such as first memory 1045. The first messageauthentication application can be configured to execute a procedure atthe handheld diabetes managing device (diabetes manager 104) forauthenticating a communication message received by a receiving device,such as the handheld diabetes managing device (diabetes manager 104)and/or the insulin pump (insulin pump 204). Similarly, the insulin pump(insulin pump 204) can include a second message authenticationapplication. The second message authentication application can beimplemented as computer executable instructions stored on anon-transitory tangible computer readable medium at the insulin pump,such as second memory 2045. The second message authenticationapplication can be configured to execute the procedure forauthenticating a communication message received by the receiving device.The procedure can include, for example, the method 900 forauthenticating a communication message received by the diabetes manager104 and/or insulin pump 204 that are described above.

The broad teachings of the disclosure can be implemented in a variety offorms. Therefore, while this disclosure includes particular examples,the true scope of the disclosure should not be so limited since othermodifications will become apparent to the skilled practitioner upon astudy of the drawings, the specification, and the following claims.

This detailed description is merely illustrative in nature and is in noway intended to limit the disclosure, its application, or uses. Forpurposes of clarity, the same reference numbers are used in the drawingsto identify similar elements. As used herein, the phrase at least one ofA, B, and C should be construed to mean a logical (A or B or C), using anon-exclusive logical or. It should be understood that steps within amethod can be executed in different order without altering theprinciples of the present disclosure.

As used herein, the term module can refer to, be part of, or include anApplication Specific Integrated Circuit (ASIC); an electronic circuit; acombinational logic circuit; a field programmable gate array (FPGA); aprocessor (shared, dedicated, or group) that executes code; othersuitable components that provide the described functionality; or acombination of some or all of the above, such as in a system-on-chip.The term module can include memory (shared, dedicated, or group) thatstores code executed by the processor.

The term code, as used above, can include software, firmware, and/ormicrocode, and can refer to programs, routines, functions, classes,and/or objects. The term shared, as used above, means that some or allcode from multiple modules can be executed using a single (shared)processor. In addition, some or all code from multiple modules can bestored by a single (shared) memory. The term group, as used above, meansthat some or all code from a single module can be executed using a groupof processors. In addition, some or all code from a single module can bestored using a group of memories.

The apparatuses and methods described herein can be implemented by oneor more computer programs or applications executed by one or moreprocessors. The computer programs and applications can includeprocessor-executable instructions that are stored on a non-transitorytangible computer readable medium. The computer programs can alsoinclude stored data. Non-limiting examples of the non-transitorytangible computer readable medium are nonvolatile memory, magneticstorage, and optical storage.

1. A diabetes care kit for providing diagnostics and therapy that ispreconfigured to reduce initial setup by a user, comprising: a handhelddiabetes managing device including: a blood glucose meter configured todetermine a blood glucose level of a user, a first processor coupled tothe blood glucose meter and configured to generate an insulin pumpcommand based on the blood glucose level, a first memory coupled to theprocessor and preloaded with an encryption key, a first communicationmodule coupled to the processor and first memory and configured togenerate an encrypted communication message based on the insulin pumpcommand and the encryption key, and a first antenna coupled to the firstcommunication module and configured to transmit the encryptedcommunication message; and an insulin pump including: an insulin dosingmodule configured to dispense insulin based on an insulin dose command,a second processor coupled to the insulin dosing module and configuredto generate the insulin dose command based on the insulin pump command,a second memory coupled to the second processor and preloaded with theencryption key, a second communication module coupled to the secondprocessor and the second memory and configured to decode the encryptedcommunication message based on the encryption key to obtain the insulinpump command, and a second antenna coupled to the second communicationmodule and configured to receive the encrypted communication message,wherein the handheld diabetes managing device and the insulin pump arepaired such that a secure bidirectional communication link existsbetween the handheld diabetes managing device and the insulin pump. 2.The kit of claim 1, wherein the handheld diabetes managing devicefurther comprises a first pairing application implemented as computerexecutable instructions in the first memory and the insulin pump furthercomprises a second pairing application implemented as computerexecutable instructions in the second memory, the first pairingapplication being configured to execute a pairing procedure at thehandheld diabetes managing device and the second pairing applicationbeing configured to execute the pairing procedure at the insulin pump,the pairing procedure pairing the handheld diabetes managing device andthe insulin pump and including: at the insulin pump, outputting a pumpidentification signal that contains a pump identification code thatuniquely identifies the insulin pump; at the handheld diabetes managingdevice, receiving the pump identification signal; at the handhelddiabetes managing device, obtaining the pump identification code fromthe pump identification signal; at the handheld diabetes managingdevice, displaying the pump identification code on a diabetes managingdevice display; at the insulin pump, displaying the pump identificationcode on an insulin pump display; at the handheld diabetes managingdevice, receiving an insulin pump selection input that selects the pumpidentification code corresponding to the insulin pump; at the handhelddiabetes managing device, generating a first verification string; at theinsulin pump, generating a second verification string; at the handhelddiabetes managing device, displaying the first verification string onthe diabetes managing device display; at the insulin pump, displayingthe second verification string on the insulin pump display; at thehandheld diabetes managing device, receiving a first confirmation inputcorresponding to the first verification string matching the secondverification string; at the insulin pump, receiving a secondconfirmation input corresponding to the first verification stringmatching the second verification string; and establishing a securebidirectional communication link between the handheld diabetes managingdevice and the insulin pump based on the receipt of the firstconfirmation input by the handheld diabetes managing device and thereceipt of the second confirmation input by the insulin pump.
 3. The kitof claim 2, wherein the pairing procedure further comprises: at thehandheld diabetes managing device, generating a test communicationmessage; at the handheld diabetes managing device, generating anencrypted test communication message by encrypting the testcommunication message with the encryption key; at the handheld diabetesmanaging device, outputting the encrypted test communication message; atthe insulin pump, receiving the encrypted test communication message; atthe insulin pump, decoding the encrypted test communication message withthe encryption key to obtain the test communication message; and at theinsulin pump, confirming receipt of the test communication message bythe insulin pump.
 4. The kit of claim 3, wherein the handheld diabetesmanaging device further comprises a first message confirmationapplication implemented as computer executable instructions in the firstmemory and the insulin pump further comprises a second confirmationmessage application implemented as computer executable instructions inthe second memory, wherein: the second message confirmation applicationis configured to execute a third procedure at the insulin pump forconfirming receipt of the test communication message at the insulinpump, the third procedure including: generating a test communicationreceived message, generating an encrypted test communication receivedmessage by encrypting the test communication received message with theencryption key, and outputting the encrypted test communication receivedmessage; and the first message confirmation application is configured toexecute a fourth procedure at the handheld diabetes managing device forconfirming receipt of the test communication message at the insulinpump, the fourth procedure including: receiving the encrypted testcommunication received message, and decoding the encrypted testcommunication received message with the encryption key.
 5. The kit ofclaim 2, wherein the handheld diabetes managing device and the insulinpump are configured to communicate by transmitting messages that areencrypted based on the encryption key.
 6. The kit of claim 2, whereinthe encryption key is an RSA public key.
 7. The kit of claim 2, whereinthe encryption key is a Twofish cipher key.
 8. The kit of claim 2,wherein the first memory is preloaded with the encryption key duringmanufacture of the handheld diabetes managing device.
 9. The kit ofclaim 2, wherein the second memory is preloaded with the encryption keyduring manufacture of the insulin pump.
 10. The kit of claim 1, whereinthe first memory is preloaded with the encryption key during manufactureof the handheld diabetes managing device.
 11. The kit of claim 1,wherein the second memory is preloaded with the encryption key duringmanufacture of the insulin pump.
 12. A method of manufacturing adiabetes care kit for providing diagnostics and therapy that ispreconfigured to reduce initial setup by a user, comprising: providing ahandheld diabetes managing device, the handheld diabetes managing deviceincluding: a blood glucose meter configured to determine a blood glucoselevel of a patient, a first processor coupled to the blood glucose meterand configured to generate an insulin pump command based on the bloodglucose level, a first memory coupled to the first processor, a firstcommunication module coupled to the first processor and first memory andconfigured to generate an encrypted communication message based on theinsulin pump command, and a first antenna coupled to the firstcommunication module and configured to transmit the encryptedcommunication message; providing an insulin pump, the insulin pumpincluding: an insulin dosing module configured to dispense insulin tothe patient based on an insulin dose command, a second processor coupledto the insulin dosing module and configured to generate the insulin dosecommand based on the insulin pump command, a second memory coupled tothe second processor, a second communication module coupled to thesecond processor and the second memory and configured to decode theencrypted communication message to obtain the insulin pump command, anda second antenna coupled to the second communication module andconfigured to receive the encrypted communication message; loading anencryption key in the first and second memory, the encryption key beingutilized to generate the encrypted communication message at the handhelddiabetes managing device and to decode the encrypted communicationmessage at the insulin pump; and establishing a secure bidirectionalcommunication link between the handheld diabetes managing device and theinsulin pump by pairing the handheld diabetes managing device with theinsulin pump.
 13. The method of claim 12, wherein establishing thesecure bidirectional communication link between the handheld diabetesmanaging device comprises: at a transmitting device, generating a testcommunication message, the transmitting device being one of the handhelddiabetes managing device and the insulin pump; at the transmittingdevice, generating an encrypted test communication message by encryptingthe test communication message with the encryption key; at thetransmitting device, outputting the encrypted test communicationmessage; at a receiving device, receiving the encrypted testcommunication message, the receiving device being the other one of thediabetes managing device and the insulin pump; at the receiving device,decoding the encrypted test communication message with the encryptionkey to obtain the test communication message; and confirming receipt ofthe test communication message by the receiving device.
 14. The methodof claim 13, wherein confirming receipt of the test communicationmessage by the receiving device comprises: at the receiving device,generating a test communication received message; at the receivingdevice, generating an encrypted test communication received message byencrypting the test communication received message with the encryptionkey; at the receiving device, outputting the encrypted testcommunication received message; at the transmitting device, receivingthe encrypted test communication received message; and at thetransmitting device, decoding the encrypted test communication receivedmessage with the encryption key.
 15. The method of claim 14, wherein thefirst memory is loaded with the encryption key during manufacture of thehandheld diabetes managing device.
 16. The method of claim 14, whereinthe second memory is loaded with the encryption key during manufactureof the insulin pump.
 17. The method of claim 14, wherein the encryptionkey is an RSA public key.
 18. The method of claim 14, wherein theencryption key is a Twofish cipher key.
 19. The method of claim 12,wherein the first memory is loaded with the encryption key duringmanufacture of the handheld diabetes managing device.
 20. The method ofclaim 12, wherein the second memory is loaded with the encryption keyduring manufacture of the insulin pump.